Cannabinoids and Cerebellar-Motor Functioning

Psychotic Disorders Clinical Trial

Official title:

Cannabinoids and Cerebellar-Motor Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853020
• Other study ID #: 1211011055
• Status: Completed
• Phase: Early Phase 1
• Start date: December 2012
• Est. completion date: April 7, 2015

Study information

• Verified date: January 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.

Description:

The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 7, 2015
• Est. primary completion date: April 7, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• Must have used cannabis at least once in their lifetime

• No cannabis use in the past month

• Men and women aged 21 to 35 years (extremes included) on the day of the first dosing

Exclusion Criteria:

• Hearing deficits

• Psychiatric or mental disorders

• Hearing Deficits

Related Conditions & MeSH terms

• Cannabis
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• THC
Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
• Placebo
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebellum Dependent Associative Learning (% CRs)	% conditioned responses (CRs) will be measured	Measured +15 minutes after infusion
Primary	Cerebellum Dependent Associative Learning (CR Latency)	conditioned response (CR) Latency will be measured	Measured +15 minutes after infusion
Primary	Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)	Total time taken to complete the grooved pegboard tasks will be the dependent measure.	Measured +45 minutes after infusion
Primary	CANTAB Motor Screening Test (Reaction Time)	Using a touch screen, reaction time to touch a target will be the dependent measures.	Measured +45 minutes after infusion
Primary	CANTAB Motor Screening Test (Accuracy)	Using a touch screen, accuracy to touch a target will be the dependent measures.	Measured +45 minutes after infusion
Primary	Paced Finger Tapping (Correct Responses)	Using a button on a computer keyboard, correct responses will be measured.	Measured +45 minutes after infusion
Primary	Paced Finger Tapping (Reaction Time)	Using a button on a computer keyboard, reaction time and tapping variability will be measured.	Measured +45 minutes after infusion
Secondary	THC intoxication, as measured by the Visual Analog Scale (Total Score)	0 being none; 100 being completely	Baseline; +45, +100, +240 minutes after infusion